NCT06326502

A Safety and Efficacy Study of Multiple Tyrosine Kinase Inhibitor Drug (ETN101) in Advanced Hepatocellular Carcinoma

An Open-label, Multi-center, Dose-escalation Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ETN101 in Patients With Advanced Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Etnova Therapeutics Corp. · Industry
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Accepted

Summary

ETN101 is a multiple tyrosine kinase inhibitor (mTKI) targeting fms-like tyrosine kinase 3 (FLT3), receptor tyrosine kinase (KIT), vascular endothelial growth factor receptor 2 (VEGFR2), and platelet-derived growth factor receptor beta. Both in vitro and in vivo studies showed that ETN101 treatment/administration inhibited cancer cell survival and proliferation. In animal models, ETN101 had antitumor activity when administered to animals that did not respond to conventional targeted anticancer agents.

Detailed description

The study drug, ETN101, is an mTKI targeting FLT3, VEGFR2, PDGFR-beta, and KIT. Based on its preclinical study results, the study drug was anticipated to have a potent anticancer effect by blocking the signaling pathway of receptor tyrosine kinases. In animal models with subcutaneously transplanted liver cancer cells (HepG2), complete remission (CR) or partial remission (PR) were observed in animals treated with ETN101 at doses of 20\~82 mg/kg. In addition, ETN101 82 mg/kg induced CR and PR in animals that had not responded to HCC therapies, sorafenib and lenvatinib. ETN101 10 mg/kg was found to have antitumor efficacy as demonstrated by approximately 30% suppression of tumor growth in comparison with a negative control. Overall, ETN101 is anticipated to have anticancer activity as a targeted therapy in the treatment of advanced HCC that did not respond to prior therapy or that recurred subsequently, and therefore, is expected to offer a new treatment opportunity for patients with advanced hepatocellular carcinoma (HCC) for whom therapeutic options are limited. Therefore, this study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of ETN101, and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of ETN101 in patients with HCC who previously had second- or further-line anticancer treatment.

Conditions

• Hepatocellular Carcinoma
• Advanced Hepatocellular Carcinoma
• Liver Cancer

Interventions

Type	Name	Description
DRUG	ETN101	Oral administration

Timeline

• Start date: 2024-02-07
• Primary completion: 2027-03-07
• Completion: 2027-06-07
• First posted: 2024-03-22
• Last updated: 2024-03-27

Locations

2 sites across 1 country: South Korea